Insertion of medical devices through non-orthogonal and orthogonal trajectories within the cranium and methods of using

ABSTRACT

The invention comprises an elongated device adapted for insertion, including self-insertion, through the body, especially the skull. The device has at least one effector or sensor and is configured to permit implantation of multiple functional components through a single entry site into the skull by directing the components at different angles. The device may be used to provide electrical, magnetic, and other stimulation therapy to a patient&#39;s brain. The lengths of the effectors, sensors, and other components may completely traverse skull thickness (at a diagonal angle) to barely protrude through to the brain&#39;s cortex. The components may directly contact the brain&#39;s cortex, but from there their signals can be directed to targets deeper within the brain. Effector lengths are directly proportional to their battery size and ability to store charge. Therefore, longer angled electrode effectors not limited by skull thickness permit longer-lasting batteries which expand treatment options.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a U.S. national phase application ofPCT/US2010/061531, filed Dec. 21, 2009, which is based on provisionalapplication No. 61/288,619, filed Dec. 21,2009, both of which areincorporated by reference in their entirety.

BACKGROUND

1. Field of the Invention

The present invention relates to medical devices, systems and methodsfor accessing cranial and intracranial structures. Specifically, theinvention is directed to altering brain function and treating cranialand intracranial pathology. More specifically, the invention is directedto the surgical implantation of electrodes or other devices within orthrough the cranium to alter or improve brain function and pathologicalstates such as stroke, seizure, degeneration, and brain tumors. Mostspecifically, the invention is directed to minimizing surgical methodsand risks and maximizing the length of devices that can be implantedwithin or through the cranium and their ability to hold charge.

2. Description of the Related Art

Electrical stimulation of the brain can improve and ameliorate manyneurologic conditions. Examples of the success of brain stimulationinclude deep brain stimulation for Parkinson's Disease, tremor,dystonia, other movement disorders, epilepsy, and pain. Additionally,potential new sites of deep brain stimulation demonstrate promisingresults for other conditions such as obesity, depression, psychiatricdisorders, memory, migraine headache, and minimally conscious states.

Deep brain stimulation involves placing a long electrode through aburrhole in the cranium to a target deep to the surface of the brain.The electrode is placed under stereotactic guidance which is performedwith or without a frame. Frame based systems such as the Leksell framerequire that a rigid stereotactic frame is clamped to the skull througha number of screws that are fixed to the cranium. Frameless systemsutilize fiducial markers placed on the skin. In both methods, an MRI(magnetic resonance imaging) or CT (computed tomography) scan isperformed with the frame or fiducial markers in place. In frame basedstereotaxy, computer assisted reconstruction of the brain and targetarea is performed to localize the target in relation to the coordinatesof the frame. In frameless stereotaxy, a three-dimensionalreconstruction of the cranium and brain is matched to thethree-dimensional configuration of the fiducial markers. The end resultin both cases is the ability to place electrodes accurately intovirtually any part of the brain.

The cerebral cortex is another structure that yields a large potentialfor therapeutic intervention. In deep brain stimulation, the electrodepasses through the cerebral cortex as well as subcortical brainstructures to reach the affected deep brain nuclei and therefore risksinjury to the intervening healthy brain tissues as well as bloodvessels. These unnecessary yet unavoidable injuries can potentiallyresult in loss of brain functions, stroke, and intracranial hemorrhage.On the other hand, stimulation of the cerebral cortex is safer becauseelectrodes are placed on the surface of the brain or even outside thecovering of the brain, i.e. dura mater, a technique called epiduralelectrode stimulation. Additionally most of the subcortical or deepbrain structures have connections with known targets in the cortex,making these targets candidates for cortical stimulation. Accordingly,directly stimulating the cortex can affect subcortical and deep brainstructures that directly or indirectly communicate with the corticaltargets. Previous studies have demonstrated success in using corticalstimulation for the treatment of epilepsy, stroke rehabilitation, pain,depression, and blindness.

In addition to the treatment of pathologic conditions, brain stimulationand recording provides the virtually unlimited potential of augmentingor improving brain function. These technologies allow the brain tobypass dysfunctional neural elements such as due to spinal cord injury,amyotrophic lateral sclerosis (ALS), stroke, multiple sclerosis (MS),and blindness. Brain recording and stimulation techniques in these casesprovide a bridge for neural signals to cross injured or dysfunctionalelements both on the input as well as the output side. For example inthe case of ALS or a patient with locked-in syndrome, the patient isawake and conscious but without any ability to interact with theenvironment. These patients are essentially trapped within their brain.Recently, it has been demonstrated that by placing recording electrodesdirectly on the surface of the brain, these patients can learn tocontrol computer cursors and other devices through their own brainwaves.This method of direct control of external devices through brainwaves iscalled brain-machine interface

Brain-machine interface has also been implemented using brainwavesrecorded outside the cranium—electroencephalography (EEG), which detectsthe neural signals passing through the cranium with electrodes placed onthe scalp. Although noninvasive, brain-machine interface using EEGsignals is currently limited from the significant dampening of thebrainwave's amplitude by the cranium. Only the largest potentials amongthe brain signals are detectable by the EEG approach.

Similarly the cortex and some subcortical fibers can be activatedthrough the cranium by transcranial magnetic stimulation (TMS) ortranscranial direct current stimulation (tDCS). In this approach,magnetic waves (TMS) or electrical currents (tDCS) are activated on thescalp outside the cranium and transmitted through the cranium toactivate parts of the cortex and subcortical fibers. TMS has beeneffective in treating a number of disorders such as depression,migraines, and movement disorders. Additionally some reports suggestthat TMS may be able to boost memory and concentration. Similarly tDCSappears to improve some forms of learning when applied in low doses.This evidence suggests that stimulation of the cortex may have a large,virtually unlimited, variety of applications for treating centralnervous system pathology as well as enhancing normal brain functions.

Electrical stimulation has also been applied effectively for thetreatment of certain tumors. By applying an electrical field thatdisrupts the physiology of tumor cells, tumors have been found toshrink. Tumors in the brain, particularly those close to the surface ofthe brain such as meningiomas may also be treated by electricalstimulation. In addition to electrical fields, heat (thermoablation) andcold (cryoablation) have also demonstrated effectiveness towards tumors.

Prior art and current state of the art for brain stimulationtechnologies require the placement of electrodes either through acraniotomy where a flap of the skull is removed and then replaced, or aburr hole where a small hole is drilled in the skull and the brain canbe visualized. These procedures necessitate a minimum of an overnightstay in the hospital and pose risk to injury of the brain due to theinvasiveness of the techniques. Additionally these “open” techniquespose special challenges for securing the electrode as most technologiesrequire a lead to exit the hole in the skull. Unless these electrodesare tethered by a suture or device, there is possibility of migration ormovement, particularly in the context of continuous pulsatile movementof the brain in relation to the skull.

Current techniques for cortical stimulation also risk the development ofscarring of the cortex as well as hemorrhage. With long term placementof foreign objects on the brain or spine, scarring (gliosis andinflammation) occurs. This is seen with both spinal cord stimulatorsplaced on the spinal cord as well as prostheses placed on the surface ofthe brain. Scarring distorts the normal brain architecture and may leadto complications such as seizures. Additionally, the placement ofdevices on the surface of the brain poses risks of hemorrhage. Aprevious clinical case illustrates the dangers: a patient who receivedsubdural cortical electrode implantation suffered significantintracranial hemorrhage after suffering head trauma. Thus in the case ofa deceleration injury like that seen in traffic accidents or falls, theimperfect anchoring of the electrode and the mass of the electode maycause the electrodes to detach and injure the brain. Blood vessels alsocan be sheared from the sudden relative movement of the electrode on thebrain, leading to subdural, subarachnoid, and cortical hematomas.However, if the electrodes were embedded within the skull then there isno risk of this type of shearing injury during traumatic brain injurysuch as from sudden impact accidents.

In order to expand the indications of brain stimulation to a largerpopulation of patients, the invasiveness of techniques for placement ofthe electrodes needs to be minimized. As many surgical specialties havedemonstrated, minimized surgical approaches often translate into safersurgeries with shorter hospital stays and greater patient satisfaction.

Recent advances in the miniaturization of microelectronics have allowedthe development of small, completely contained electrode systems, calledthe bion, that are small enough to be injected into muscle and otherbody parts through a syringe. This type of microelectrode devicecontains stimulation and recording electrodes, amplifier, communication,and power components all integrated into a hermetically sealed capsule.While some bion devices have batteries integrated with the unit, othersare powered by radiofrequency transmission. Although muscle and otherbody parts allow the implantation of bion electrodes, the cranium posesa challenge to the bion because the cranium is roughly 1 cm or less inthickness. This finite thickness limits the size of the electroniccomponents as well as the size of the battery. Battery capacity (theamount of energy stored within the battery) determines the length oftime between charges in a rechargeable battery and is effected by thelength of the battery. In the case of the bion, an injectable devicethat demands a small diameter, the battery capacity is directly relatedto the length of the battery. A longer bion electrode permits a longerbattery and hence greater battery capacity and a longer run time withoutrecharging.

Some patents exist covering implantable stimulators and electricalstimulation therapy systems. However, these patents are not speciallyadapted for insertion through the skull with multiple components througha single site by means of introducing some components at non-orthogonalangles.

In the present invention an electrode can communicate with and worktogether with other electrodes and supporting components (i.e.receivers, transmitters, batteries, rechargers, etc.) for an integratedtherapy system with multiple components insertable through the same

BRIEF SUMMARY OF THE INVENTION

The invention involves an improved method of implanting effectors,sensors, systems of effectors and sensors, and other implantable medicaldevices into the body through skin, bone, muscle, tissue, and otherintermediary material between an external surface of the body and theintended physical contact. The physical contact within the body may bethe target from which information is gathered with the sensors or towhich energy is directed with the effectors. Alternatively, the physicalcontact may be a transceiver station from which information is receivedby the sensor from another target (deeper inside) or from which energyis sent by the effectors to another target (deeper inside). Whenimplanted into the cranium the devices of the present inventiondescribed herein are referred to as a Cranion™.

The effector may include any component that produces or induces aneffect or acts as a stimulus at a target within the body. A preferredexample of an effector is an electrode producing an effect throughelectricity. Other types of effectors produce effects using magnetism,temperature, infrared radiation, light, vibrations, hypersonic energy(frequencies above human hearing), ultrasonic energy, radiowaves,microwaves, etc. and include transmitters of these other forms ofenergy.

The sensor may receive and record data relating to temperature, light,density, impedance, etc., in the form of radiowaves, microwaves,spectroscopy, etc.

According to a preferred embodiment, the invention focuses on improveddevices and methods for implantation through the cranium to providebrain therapy and therapeutic treatment of medical conditions having aneurological component.

The improved method involves modification of implantable devices tospecific sizes and shapes so that one or several can be insertedsimultaneously through a single entry site in the cranium by alteringthe insertion angle of each unit. The individual units are insertedorthogonally and/or nonorthogonally relative to the surface of thecranium tangent to the singular common entry site. The individual unitsmay be physically connected through a connector head at the common entrysite, thereby sharing electronics, power, and other attributes.Additionally, in some embodiments, the distal tip of the shaft and theshaft of the device may be configured so that the devices are insertabledirectly. By insertable directly it is meant that no or few other toolsor instruments are needed to make the entry site and/or the hole throughwhich the implanted device is inserted. For example, the device may beencapsulated in a helical externally threaded screw housing such thatthe shaft has a sharp distal tip allowing the whole device to piercethrough the skin and screw into bone similar to currently usedself-drilling cranial plating screws. The self-inserting characteristicenables electrodes to be inserted almost anywhere very quickly in aminimally invasive screw-in or pop-in procedure.

The types of medical devices that can be modified and implanted by themethods described in this invention are virtually unlimited and includeneural stimulation systems, neural recording systems, brain machineinterface systems, cryotherapy systems, thermotherapy systems, magneticfield generating systems, radiation emitting systems, auditory systems,iontophoresis systems, interpersonal communication systems,interorganism communication systems, et al. Currently, electrodes placedon or near the surface of the brain have been used clinically to treat anumber of disorders including seizures, pain syndromes, movementdisorders, psychiatric disorders, paralysis, and neurodegenerativedisorders like ALS. One preferred embodiment of the invention is toimplant one or more cortical stimulation and recording electrodes closeto the surface of the cortex through a single minimally invasive cranialentry site while enhancing the battery life and complexity of eachelectrode unit by allowing each unit to be greater in size (particularlylength) than the thickness of the skull since they are adapted forinsertion at an oblique angle and not limited to perpendicularinsertion. However, consistent with the present invention, someelectrodes (or other effectors) can be also be equal to or shorter thanthe thickness of the skull. Multicomponent devices and systems ofdevices with shorter electrodes (or other components) adapted forinsertion of shafts at a variety of angles permits more components thanpreviously possible through a single entry site. The electrodes may takethe form of an implantable microstimulator or improved bion that isembedded in the skull with its tip placed either epidurally (upon thedura mater) or subdurally (below the dura mater) near the surface of thebrain.

The thickness of the cranium is limited to a length of 5 mm to 10 mm. Ifelectrodes are inserted straight down, perpendicular (orthogonal) to thesurface of the cranium, their lengths would be limited to a maximum ofapproximately 1 cm. Electrodes longer than 1 cm that are implanted inthe cranium orthogonally would protrude through the skull into thebrain. Placement of electrodes into brain substance increases the riskof injury to brain and blood vessels both during the time of placementas well as afterwards given the physiologic pulsation of the brain inrelation to the cranium as well as during episodes of head trauma whichcauses acceleration and deceleration movement of the brain in relationto the cranium. Current methods of cortical stimulation place electrodeseither epidurally (outside the dura mater) or subdurally (in between thedura mater and arachnoid or epi-arachnoid). Placement of electrodes ineither of these locations provides for low impedance stimulation of thebrain while maximizing safety. Current methods of placement of corticalelectrodes necessitates drilling of a burr hole or craniotomy, both ofwhich pose risks to the patient and commonly require a stay in theintensive care unit to monitor postoperatively.

The current invention describes the method of insertion of devices andelectrode units through orthogonal and nonorthogonal trajectoriesthrough the cranium. Angled insertion of the electrode units enableslonger units (length greater than skull thickness) to be used withoutpenetrating into the brain. The angled electrodes pass almost entirelythrough the skull and then just barely protrude towards cerebral cortex.Longer electrodes units are desirable because the length of a battery isproportional to the size and capacity of the battery. Thus longerelectrode units can contain longer and larger batteries. Preferably, thebatteries are rechargeable. However, regardless of whether the batteriesare rechargeable, it is desirable for the stimulation electrodes to havea maximum battery capacity (time until replacement or recharging).Higher capacity batteries provide sustained therapy and enhance patientmobility and freedom. The greater mobility and freedom provided byhigher capacity batteries in longer electrodes increases the probabilityof patient compliance for out-patient procedures because it is easier tocomply with prescribed therapeutic regimens while living a normal life.

Longer electrodes units also allow more components to be integratedwithin each implant. Larger size allows flexibility in terms of thecomplexity of the circuitry, communication components, as well as theinclusion of both recording (receiving) and stimulation (transmitting)capabilities. Additionally, multiple electrode contacts can be placedwithin a single implant with greater ease, i.e. bipolar, tripolar,tetrapolar stimulation or recording within each electrode unit.

The ability to insert several electrodes units through a single cranialentry site is highly advantageous. The cranium obviously provides animportant protective function for the brain. Accordingly, it isdesirable to keep the cranium as intact as possible while accessing thebrain for therapy. Fewer entry sites in the cranium preserve itsintegrity and reduce the likelihood of the brain inadvertently beingexposed or harmed. However, if fewer entry sites imply fewer electrodesthis may have drawbacks with respect to the variety and intensity oftherapy that can be provided. The ability to insert several electrodesthrough a single site provides powerful therapy without jeopardizing thecranium and more importantly, the brain and blood vessels beneath. Whenmore intense therapy is not needed, multiple electrodes in the sameregion may still have advantages because they can be selectively,individually activated to prolong the time until recharging. Forexample, with electrodes radiating outward in a circle from a commoninsertion point, when the battery of the first electrode dies the systemcan automatically or manually advance to turn on the next electrode forit to begin stimulation. Additionally multiple electrodes positioned ina spatially dispersed pattern in two or three dimensional space allowsthe stimulating current to be steered in that space. Current steeringhas been utilized in spinal cord stimulation and is performed bydifferential activation of spatially distinct electrodes. Differentelectrodes or other components (i.e. sensors) inserted through a commonentry site may also be used to provide different therapeutic benefits(electrical stimulation, magnetic stimulation, drug delivery, etc.) orto gather different types of data (blood glucose level, temperature, pH,etc.).

The stimulation module is designed as either a single implant in asingle trajectory or multiple implants with multiple trajectories.Depending on the specific need of the individual, the stimulation modulemay contain one, a combination, or all of the following components:stimulation electrode(s), recording electrode(s), pulse generator,system control unit, battery, capacitor, current sink, data signaltransmitter, data signal receiver, receiver coil, transceiver,transducer, sensors, program storage, memory unit, internal electronics,analysis circuitry or software, etc. All of these components can becontained within a single implant similar to a bion. However, thesecomponents can also be broken down into separate units that areimplanted in separate trajectories. Because the units pass through asingle entry site, they can be hard wired at this point. Optionally,they may communicate wirelessly with each other. For example, if anindividual wanted or needed an implant with a longer battery life, thenmultiple units composed of batteries can be implanted and wiredtogether. Since the battery units do not need to contain an electrode orpass through the inner table of the skull, battery units can beimplanted in a trajectory with the maximum length permitted by thecurvature of the cancellous portion of the cranium without passingthrough the inner or outer cortical layers of the cranium. Non-rigidunits that curve with the curvature of the cranium permit even longerimplants. These curved electrodes can slide into the cancellous skulltrapped in between the inner and outer cortical layers. The curvedstimulators and electrodes do not have to be stiff or rigid but can besemi-flexible to more easily slide into and maneuver within thecancellous space. In fact only the actual electrode contacts need topass through the cranium into the epidural or subdural space. All othercomponents can be implanted within the cranium without exiting thecranium. This system is customized with the modules or componentsspecific for each individual, each brain target, and each specificpurpose or disorder that is being treated.

The implantable stimulating electrodes and associated componentsprovided herein have a plethora of uses. In addition to existingapplications of neuromodulation in Parkinson's Disease and epilepsy,they can be used to stimulate a healthy, normal brain to enhance memory,accelerate learning, etc. (See Singer, Emily, “Want to Enhance YourBrain Power? Research hints that electrically stimulating the brain canspeed learning”, MIT Technology Review, Jun. 26, 2008; and Giles, Jim,“Electric current boosts brain power” in Nature, Oct. 26, 2004.) Theycan also be used on a damaged brain to stimulate regeneration, repair aswell as to record changes to enable a patient (including non-humanpatients such as animals) to communicate with the outside world simplyby using their brain. This offers hope for patients with paralysis afterstroke, spinal cord injury or other disorders (ALS, polio, etc). Anotherapplication is to use the implantable cranial electrode as means forbrainwave communication between people or other living organisms so thatwith training, one person (or other living organism, including otheranimals and potentially plants) can learn to recognize specific patternsof neural signals from another. In this manner it may be possible forpeople and other living organisms to have invisible, inaudibleconversations using only their thoughts and brain waves. This technologyhas important commercial as well as military applications. Additionallyimplantable units do not have to access the brain for communication;instead, vibrations generated by implants positioned elsewhere candirectly stimulate the inner ear for communication. For example, thestimulator (with multiple components at multiple angles through a singlesite) may be used as a transmitter and receiver in the inner ear withthe capacity to interact with a cell phone (such as via Bluetoothtechnology) for hands free conversation. Related ear devices have shownsuccess when used in partially deaf people (or other animals) totransmit auditory signals to the opposite ear as in cases of outer earor one-sided deafness.

Although electrode stimulation and recording has a wide potential ofuses mirroring those currently in use clinically, other preferredembodiments are plentiful. Another preferred embodiment is an implantthat uses temperature differences to activate or deactivate the brain orintracranial tissue. In this embodiment, the heat conducive element isimplanted through the cranium into the subdural or epidural space. Thecomponents that are implanted through other trajectories include thosedescribed in the electrode embodiment described above, but also includeheat pumps, thermogenerators, and thermoregulators. Cooling the braintypically deactivates the neural activity and can be utilized forseizures, migraines, pain, and other disorders.

The electronic circuitry of the present invention is amenable to variousconfigurations or embodiments. The invention covers the electroniccircuitry configurations of any conventional electrodes, stimulators,bions, etc. adapted for insertion of multiple components transverselythrough the cranium at orthogonal and/or non-orthogonal angles.

Other objectives and advantages of the invention will be set forth inthe description which follows. Implicit modifications of the presentinvention based on the explicit descriptions will be, at least in part,obvious from the description, or may be learned by practice of theinvention. Such subtle, predictable modifications and adaptations aretaken to be within the scope of the present invention. Additionaladvantages of the invention may be realized and obtained by means of theinstrumentalities and combinations particularly pointed out hereinafter.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the invention, andtogether with the general description given above and the detaileddescription of the embodiments given below, serve to explain theprinciples of the invention.

FIG. 1 shows how the trajectory of each device or shaft at a particularentry site is defined by an axial angle (θ₁) (FIG. A) and a radial angleθ₂ (FIG. B). The skull is represented by a hemi-sphere with 2 crosssections in (A) and 1 cross section in (B). FIG. 1A shows twonon-orthogonal trajectories both of which have the same axial angle (θ₁)with respect to the perpendicular axis at the entry site. The radialangle (θ₂) is the angle on the tangent plane to the skin or skull at theentry site. For convention anatomic anterior orientation, i.e. thedirection towards the front of the face, or the component of theanterior orientation projected onto the tangent plane at the entry siteis taken as zero degrees.

FIG. 2 shows multiple devices from different entry sites, but angledsuch that they converge on the same target within a brain from differentdirections.

FIG. 3 shows multiple devices inserted from a single entry site atdifferent angles that are divergent from the entry site in order to aimat different targets within a brain.

FIG. 4 demonstrates the geometric relationship between the axial angleof device insertion (θ₁) and device length (l) for straight (non-curveddevices) that completely traverse a skull thickness (t) based on alateral displacement variable (x) when the device is fully inserted, sinθ=x/l.

FIG. 5 illustrates the relationship between the thickness or diameter ofthe device and the maximal length of the device when the device isimplanted at an increasingly greater axial angle (θ₁), i.e. greaternon-orthogonal insertional angle. FIG. 5A. shows that a thinner devicewith smaller diameter can have greater length with greater axial angleof insertion (θ₁). However when the device has a diameter similar to thethickness of the skull, as shown in (B), the length of the device cannotchange with any axial angle of insertion (θ₁). FIG. 5B also shows thatas the axial angle increases, the tip of the larger diameter device isno longer able to penetrate the inner cortical layer of the skull.Instead the side of the device penetrates the inner cortex. In contrast,(A) demonstrates that a thinner device is still able to penetrate theinner cortex with the tip at greater axial angles (θ₁). Thus in general,non-orthogonal insertion of devices requires that the width or diameterof the device be less than the thickness of the skull.

FIG. 6 illustrates a device comprised of four multiple shafts andcomponents arranged in a linear array on the cortex. FIG. 6A. shows anbroad top view while (B) shows a side view, and (C) shows a view frominside the cranium. A single small burr hole is used to insert all fourshafts. The single burr hole is of partial thickness because the edgesat the bottom of the partial burr hole are used to guide the tips of theself-drilling shafts or drill bits. Two longer shafts flank two shortershafts resulting in a linear array as seen in (C) where four tips of theshafts are seen protruding through the inner cortex. A linear array ofstimulation as shown in FIG. 6 is useful for stimulation along a lineargyms such as for motor cortex stimulation, where typically a smallcraniotomy is used to place a strip electrode.

FIG. 7 illustrates a device comprised of nine different shafts placedthrough a single partial small burr-hole. The overall configuration isdemonstrated in the cross section of the skull model with threedifferent views in (A), (B), and (C). A top view (D) and bottom view (E)demonstrate the arrangement of the contacts that penetrate through theinner cortex to affect the brain. Four shorter shafts are configured ina “+” configuration while four longer shafts are inserted in an “X”pattern. A central shortest shaft is inserted last. This configurationresults in a 3 by 3 matrix of components that can reach the cortex. Thistype of configuration is useful for epilepsy stimulation where thecentral electrode senses seizure activity at the seizure focus. Thiscentral electrode then activates its own stimulation electrode to abortthe seizure. At the same time, the 8 surrounding ring of electrodes areactivated as well. The activation of the ring of electrodes help to trapand cancel the spreading wave of seizure activity from the centralepileptogenic focus. Such a configuration would generally necessitate acraniotomy; however this configuration is placed through a singlepartial burr hole.

FIG. 8 illustrates a shaft inserted at an axial angle that serves as aconduit for a guidable and steerable epidural or subdural electrodearray. FIG. 8A. shows the drilling of a non-orthogonal hole through thecranium by a self-drilling shaft. In (B), an inner compartment of theshaft is unlocked and removed from the outer threaded portion, leaving acylindrical conduit. This conduit allows one or more electrode arrays tobe inserted into the epidural or subdural space (C). The angled,non-orthogonal trajectory of the shaft allows the electrode array tosafely slide into the epidural or subdural space at a shallow angle. Incontrast if the burr hole were orthogonally oriented, the electrodearray would have to make a 90 degree turn after passing through theskull. The electrode arrary can be directed similarly to spinal cordstimulation electrode array using mechanical turning by a small bend inthe distal tip of the inner stylet. Alternatively, the distal innercannular may be ferromagnetic allowing an external magnetic orelectromagnetic field to guide or direct the tip of the electrode array.Lastly, a fibroptic inner cannula with distal camera would allowendoscopic guidance of the electrode array under direct visualization ofepidural, subdural, or intraventricular structures. The tip of thestylet also would allow for stereotactic image guidance by emittingsignals such as radiofrequency or sonic/ultrasonic impulses that helplocalize the distal tip in stereotactic coordinates. Once the target anddesired placement of the electrode array has been accomplished, theproximal end is secured to the cranial conduit/shaft by a lockingmechanism. Alternatively, other components such as a battery,controller, transducer, etc. can also be placed inside the cannula, orin other trajectories through the cranium from the same entry site. Thecombination of multiple shaft placement through a single entry site withmultiple steerable electrode arrays allow a limitless configuration ofbrain stimulation and recording through a single small burr hole.

FIG. 9 demonstrates a simple connection system to physically linkmultiple shafts and components that are placed through a single ornearby entry sites. The connector shown is a multichannel connector, butany connector would suffice including USB or micro USB connectors. Whilethe components can communicate wirelessly with each other with theappropriate components included within the shaft, some functions aremore efficient through direct physical connections.

FIG. 10 demonstrates a preconfigured head unit used to facilitate theplacement of multiple shafts and multi-component arrays. FIG. 10A. showsthe empty head unit with three docking stations. FIG. 10B shows theinsertion of a single shaft into one docking station. Two shafts areinserted into the head unit in (B), while all three shafts have beeninserted in (C). The head unit allows direct communication andconnection between all shafts and components of the shafts. The headunit itself can also contain multiple components of the overall devicesuch as battery, communication systems, transducers, etc. The head unitcan be inserted into a pre made burr hole or be self-inserted by havinga self-drilling and self-tapping pointed tip. The head unit does notneed to have its own fixation to the skull as the insertion of shaftsthrough the docking stations acts to lock the docking station into theskull. Each docking station can also have adjustable angles of insertionby having a rotating ball and socket mechanism as the docking stationthrough which shafts are inserted.

FIG. 11 shows a flow chart of a method of implanting the devicesdescribed herein: (I) identify the target, (II) create an incision,(III) drill a partial thickness burrhole, (IV) identify target and depthfrom partial thickness burrhole, (V) insert device(s), and (VI) closewound.

DETAILED DESCRIPTION OF THE INVENTION

The present invention and method of its use enables multiple effectors,sensors, and other components to fit through a single entry site toprovide improved and/or longer-lasting therapeutic benefits. Accordingto some embodiments this is accomplished by inserting the effectors,sensors, other components, or shafts housing any of these elements atdifferent angles to permit greater subsurface reach given a smallsurface entry site. As used herein, the term “entry site” includes oneor more physically distinct openings, holes, or incisions, within closeproximity to one another and taking up a relatively small total area ofspace consistent with minimally invasive surgical procedures. Thus, an“entry site” may be one opening or hole but is not limited to such. The“entry site” may also be an entry zone, area, or region that encompassestwo, three, four, or more distinct openings.

For each entry site, the stimulator/sensor devices may be inserted atseveral different axial angles between an axis perpendicular to theskin's surface (straight down) and a plane tangent to the skin's surfaceat the entry site. The effectors (i.e. electrodes) and/or sensors mayalso be inserted at several different radial angles around the peripheryof an entry site in the plane of the tangent to the entry site. Thelocation of the entry site, the axial (θ₁) and the radial (θ₂) insertionangles determine an unique trajectory in the skull and in the body.Preferably, no two stimulator/sensor devices (comprising at least oneeffector or sensor as part of the device) have the same set of axial(θ₁), radial (θ₂) angles, and entry site location so that each device(and each effector or sensor therein) occupies a unique positiondifferent from the others. The closer the first diagonal axial angle isto parallel to the skin surface, the longer the effector or sensor canbe while still traversing substantially laterally through the skullwithout reaching the brain. Conversely, the closer the first diagonalaxial angle is to perpendicular to the skin's surface (straight down),the shorter the effector or sensor must be because it is moving moreclosely to vertical though the skull and is thereby more strictlylimited by the skull's vertical thickness. (See FIG. 1.)

Angled implantation allows implantation of extra components to supportor work together with the effector or sensor (i.e. electrode) to form alonger-lasting system or improved bion. For example, the main device maybe implanted perpendicularly but one or more components (i.e. extendedbatteries or battery packs) are implanted at an angle. This allows extracomponents that support a main electrode to be embedded within the skullat an angle. More supporting batteries prolongs the life of theelectrode while effectively breaking up the overall implant into severalcomponents that are connected (i.e. at the top) by a connector head orconnector. Other components, in addition to batteries, can betransmitters, receivers, radio transceivers, heat generators, coolingdevices, magnetic coils, capacitors, transformers, ultrasonictransducers, hypersonic emitters/receivers, electrophysiologicalrecording means, sensors, iontophoresis means, optical stimulators,lasers, cameras, address/positioning units, etc.

As used herein, the term “component” includes effectors and sensors butis not limited to these categories. “Component” might also include othercategories of auxiliary, complimentary, or supplementary elements thatsupport an effector or sensor but do not themselves produce an effect ona body or sense (gather data) directly. For example, “component” mightinclude a buffer solution, a physical cushion, a catalyst, a battery, avacuum line, etc. The present invention includes an implant in which atleast one component is an effector or sensor. The implant may alsoinclude other additional components that are also effectors or sensors,or are neither effectors nor sensors.

The implantable devices described herein are made of biocompatiblematerials. In a self-inserting embodiment the devices need to be made ofmaterial sufficiently durable and hard to penetrate bone withoutrupturing. In embodiments that rely on pre-drilling a hole more materialoptions are possible and softer, more flexible materials may be used toencapsulate or house the device. According to a preferred embodiment, atleast a portion of the device is made of a semi-permeable material thatabsorbs some molecules, transmits (flow through) some molecules, elutessome molecules, and blocks some molecules. Such a semi-permeablematerial may be a mesh with openings (for example, tiny nanopores)therein that optionally also includes key cells or molecules (thatprovide an auxiliary function) embedded therein on its surface.

According to a preferred embodiment, the effectors are electrodes andsupporting components (i.e. transmitters, receivers, etc.) of thepresent invention are designed to be insertable directly or to insertthemselves. By “insert themselves” or “insertable directly” it is meantthat the components do not require burr holes to be created in the skullwith a drill prior to implant and/or that the components do not requireexpulsion through an introducer (i.e. needle, cannula, etc.). Selfinserted screws of this type are typically classified as self-drillingand self-tapping, in that they do not need a pilot hole nor does thehole need to be tapped to form the threaded tract for a screw. Thismight be accomplished by the components having distal tips that aresharp or a housing that resembles a screw shaft with threads.

Alternatively, the cranial stimulator devices can be helical in shapesuch that they wind into the bone in a manner similar to coil anchorsfor sand volleyball nets. The distal tip of the helix enters into asmall hole and the curved tail of the device follows.

When drilling into the skull is necessary such as due to increasedresistance from bone making self-tapping screws inadequate, a preferredsystem and method involves using a balloon along one or more sides ofthe stimulator device. Drilling often creates a hole that is slightlylarger than necessary or imperfect in shape such that there is not atight fit for the screw. The balloon can be filled with air and or fluidafter insertion in a deflated condition to close the gap, reducing theimperfect mating between drill hole and stimulator to provide animproved friction fit that renders the stimulator less susceptible tointernal drift/migration. The balloon can also be used proximally abovethe stimulator to push the electrode contacts on its opposite distal endinto closer contact with the surface of the cortex.

If the effectors contain, are coated with, or are associated withmagnetic means (i.e. coils, magnetic materials, etc.) they can be usedto provide magnetic stimulation therapy in addition to electricalstimulation therapy. Magnetic energy can also be used to recharge theelectrical batteries. For example, inserting a magnetic coil inside theskull enables one to carry out local magnetic stimulation (“intracranialmagnetic stimulation”) with a much lower intensity than that used fortranscranial magnetic stimulation which requires a large enough magneticfield to travel through the cranium (resulting in a diminution of signalstrength in the process) and also is not localized. The inability tolocalize therapy, also known as poor selectivity, typically results inoverbroad application that may cause damage to unintended surroundingregions and too weak an intensity of treatment at the target site. Theability to localize therapy overcomes both of these drawbacks tosystemic application.

In addition to electrical and magnetic stimulation the implantableelectrode or components associated with it can be used to generate heator cold. Heat and cold have been shown to influence brain activity suchthat they can be used to complement, supplement, or as an alternative toelectrical and/or magnetic stimulation.

In addition to electrical and magnetic stimulation the implantableelectrode or components associated with it can be used to generate heator cold. Heat and cold have been shown to influence brain activity suchthat they can be used to complement, supplement, or as an alternative toelectrical and/or magnetic stimulation.

In different embodiments the effector batteries can be recharged insideor outside the body or inside the body through connection to a chargingdevice outside the body. According to a preferred embodiment theeffector batteries are recharged inside the body through a naturallyoccurring means including changes in heat, fluid dynamics, etc. Thebatteries may include a thermogenerator or thermoelectric generator thatuses local heat in situ to generate power. Or, the batteries may includea mechanical power generator that uses natural pulsation of the brainrelative to the cranium and changes in cerebrospinal fluid pressure toharness and store energy.

In addition to built-in electrode batteries, the implantablesensor-effector devices of the present invention may be powered by anynumber of alternative means. In order to reduce their size, they may bepowered from outside through a means for receiving energy with the meansfor receiving energy being smaller than a conventional electrodebattery. More specifically, they may rely upon ultrasonic, hypersonic,or radiofrequency energy from a source at another location in the bodyor outside the body that is absorbed and channeled through a receivingplatform. These alternative sources of energy permit the devices to besmaller because a built-in battery is not required. Thus, the device maybe made on the scale of microns (length, width, height) rather thanmillimeters and inserted more deeply into the body, into smallerchannels and crevices, or through intact bone and muscle for betteraccuracy while still being minimally invasive and without sacrificinganatomical structural integrity. Another advantage of the energy sourceand some of the electronic complexity being outside the body is that itis easier to upgrade and modify from outside. Another advantage ofeffectors radiating downward and outward from an entry site at differentangles is that when a target region for stimulation is deeper within thebrain the angle(s) can be set so that rays from more than one effectorconverge precisely on the deeper target. More than one entry site can bemade so that several different devices from several different entrysites converge on the target from different directions (see FIG. 2).Alternatively, when there is more than one target region deep within thebrain, effectors from a single entry site can be used to simultaneouslyreach several different regions by directing the effectors at differentangles (see FIG. 3). If the effectors were limited to non-angled,conventional, straight-down insertion all effectors (even throughmultiple entry sites) would be pointed at the core or center of thebrain without the ability to provide targeted therapy to intermediateregions of the brain between the core and the cortex.

In alternative embodiments, the effectors may have additionalcharacteristics that enable them to jointly maximize length and distancewithin the skull. For example, the effectors may curve with a radius ofcurvature that approximately matches the radius of curvature or shape ofthe skull. Since the cranium is composed of three layers, a hard innercortical layer, a hard outer cortical layer, and a softer cancellousmiddle layer, long components can be pushed through the cancellous layerbeing trapped by the harder inner and outer cortical layers.Additionally, the devices may branch out (for example, telescopically)once inserted to form an intracranial pathway that provides additionalbattery power storage space. However, because the branches would have totraverse through the somewhat hard bone of the cranium these(bifurcated, trifurcated, poly-furcated) embodiments would probablyrequire separate insertion tools capable of drilling worm-like tunnelsfor the branched devices.

When the effectors are electrodes the circuitry of the present inventionfor all embodiments is variable. By electronic circuitry it is meant thearrangement and interrelationship between electrodes, batteries,connectors, coils, transmitters, receivers, transceivers, capacitors,controllers/programming means, address means, pulse control means,sensors, etc. Any configuration of these elements that is functional formultiple electrodes inserted transversely through a single entry site(at orthogonal and/or non-orthogonal angles) is consistent with thescope of the present invention.

In other embodiments, the configuration of electronic circuitry isdistinctly different in one or more features from conventional productsand patent claims, which serves to further distinguish the invention inaddition to its other distinguishing features.

As discussed previously, as neurostimulators the devices of the presentinvention have a myriad of established applications to improvepathologies (movement disorder, psychiatric conditions) and enhancenormal functions (learning, memory) in the neural system, particularlythrough direct interaction with the brain. Additional, potentialapplications include peripheral nerve stimulation and interaction withother biological systems to catalyze and regulate healing processes. Forexample, implantable stimulators as described herein may be used atsites of bone fracture or disc degeneration to expedite new boneproliferation as a substitute or supplement to biological or chemicalmeans (bone cement, bone graft, bone filler, bone glue, hydroxyapatite,ground bone composition, or another bone substitute). One specificapplication is use of stimulators around pedicle screws used in pediclescrew stabilization/fusion of adjacent vertebrae to stimulate boneregrowth over the screws to better camouflage the implants.

According to a preferred embodiment, the devices described herein areused to enable communication between two or more entities with at leastone entity being a living organism. The other entities may be otherliving organisms of the same or a different species as the first livingorganism, or may be a machine including but not limited to a computer, alaptop, a cell phone, a personal digital assistant (PDA), a keyboard, acamera, a wheel chair, a bicycle, a car, etc. The communication can beone-way, two-way, or a multi-channel exchange amongst several differententities (group conversation, or different entities all communicatingwith a centralized hub).

In this method of enabling communication between at least one livingorganism and at least one other entity a device comprising an effectorand a sensor is implanted in the living organism. At least oneadditional component is implanted in the other entities to interact withthis device. The sensor in the first entity (living organism) gathersdata and generates a pulse that transmits the data to the otherentities. The other entities receive the pulse through their componentsthat read and translate it. In this manner the first entity (livingorganism) can relay information or “talk” to the other entities in openloop communication. In an alternative embodiment, the device in thefirst entity further comprises at least one feedback component and thecommunication is closed loop with the feedback component in the firstentity verifying receipt of the pulse from the first entity by thesecond entity.

When receivers or transceivers are used to receive signals they may beused alone to receive signals directly or they may be used inconjunction with one or more intermediary devices that relay and/orprocess the signal prior to its reception. The intermediary device mightamplify or reformat the signal and eliminate noise. In some embodiments,for some applications, the intermediary device could be somethingsimilar to a bluetooth earpiece, a cell phone, a wifi router, an aircard, etc. Likewise, when effectors are used to induce an effect in anentity (machine or organism) they may induce the effect directly orthrough one or more intermediary devices that adjust or process the rawinformation and energy they provide.

The devices described herein are contemplated to be adaptable for usewith state-of-the-art sixth sense and mind control devices. Theminimally invasive implants of the present invention may be moreconvenient than headgear and may be used to read neural states andobjectives to initiate actions in the outside world rather than relyingon hand gestures from the living organism subject or patient. As usedherein (before and after), the term “patient” refers to any object thatsubjects itself or is subjected to a treatment incorporating the presentinvention. A “patient” need not be an ill person or someone withphysical, emotional, or psychological impairments or abnormalities. Infact, a “patient” need not be a human being or even a living organism. A“patient” may include completely healthy, happy, and successfulorganisms or objects that choose to subject themselves to treatment orare subjected to treatment with the present invention in order tofurther their abilities and become even more successful or to improvecertain functions.

Examples of conditions the devices of the present invention can be usedto treat include: psychological conditions generally, genetically orbiologically based psychological conditions, depression, acute mania,bipolar disorders, hallucinations, obsessions, obsessive compulisivedisorder, schizophrenia, catatonia, post-traumatic stress disorder, drugand alcohol addiction, Parkinson's disease, Alzheimer's disease,epilepsy, dystonia, tics, stuttering, tinnitus, spasticity, recovery ofcognitive and motor function following stroke, pain syndromes, migraine,neuropathies, back pain, internal visceral diseases, urinaryincontinence, etc.

Specific medical applications include using the cranial implants of thepresent invention as follows: (i) enabling a paralyzed man to sendsignals to operate a computer by “telepathically” moving a mouse,cursor, or typing on a keyboard, improving one's ability to work; and(ii) enabling a paralyzed man to send a signal causing a machine orcomputer to speak a phrase or message for them so that they cancommunicate their needs, desires, and thoughts to others and the world.

Specific entertainment and social applications include using the cranialimplants of the present invention as follows: (i) a person has aCranion™ implanted so that he can use it to control his iPhone or Wiigame console without using his hands or in addition to hand controls;and (ii) a person has a Cranion™ implanted to communicate with one ormore other persons, each with his own Cranion™ implanted to enableprivate “telepathic” conversations in a group of people including at ameeting, in church, in the courtroom, at a sporting event, and during acard game.

Implanted devices of the present invention (especially those in thebrain) may be used to control a projector, a camera, a laser, a bar codereader, etc. worn on the body. Such sixth sense and mind control devicesmay find application for video games, electronic transfers of money,trading stocks, shopping, social and professional networking and storageof data about people, filming, photography, etc. The implants could beused to read expressive conditions (facial expressions, gestures) andemotional experiences (affective response) of the living organism inwhich they are implanted or of others with whom the patient comes incontact. The implants could then process and analyze this information toinitiate cognitive actions in response thereto.

It is known that an electrical signal at the cortex of the brain looksrandom across the population for the same thought, even though itoriginates from the same region of the brain, due to a unique foldpattern of each person's brain similar to fingerprints. Headgear uses amathematical algorithm to unlock the random signal to make it consistentacross the population. Alternatively, the implants of the presentinvention might be used (i) to read the signal from a source in thebrain beyond the cortex where it is uniform without the algorithm, (ii)apply the algorithm to data read at the cortex, or (iii) to provide aninitial equilibration process that compensates for the differences insignals from one person to another.

According to still other embodiments, the Cranion™ has a longerelectrode lead that passes through the skull at an angle and goesepidural to distant areas like a spinal cord stimulator sliding up theepidural space in the spine. This tip may then be steerable, forexample, with a magnet.

The general method, as summarily illustrated in the flow chart of FIG.12, in greater detail may encompass the following sequence:

-   -   1.) Use stereotactic localization, either with a frame or        frameless stereotactic localization to identify a target(s);    -   2.) Decide on a configuration. For example, either single        electrode, multiple around the single target, single line (see        FIGS. 7 and 8);    -   3.) Single stab incision 5-10 mm;    -   4.) Drill 2-4 mm partial thickness burrhole (this allows an        “edge” so that drills can be angled into the corner and an off        angle trajectory can be accomplished;    -   5.) Use stereotactic localization to identify target and depth        away from the central partial burrhole;    -   6.) Plan trajectory based on the target and either drill a pilot        hole or use a self drilling, self tapping Cranion™ to insert the        Cranion™ device;        -   6a.) Drilling a pilot hole allows exact knowledge of the            depth of the hole however a cannulated Cranion™ in which the            sharp tip can be removed (see FIG. 9) also allows a portal            to determine whether the epidural space has been entered.    -   7.) Place other Cranions™ and connect them with wires (see        FIG. 9) or have them connect wirelessly. Or, use the head        device.    -   8.) Add other components such as extra batteries that don't need        to go all the way out of the skull.    -   9.) Close the wound

The present invention is not limited to the embodiments described above.Various changes and modifications can, of course, be made, withoutdeparting from the scope and spirit of the present invention. Additionaladvantages and modifications will readily occur to those skilled in theart. Therefore, the invention in its broader aspects is not limited tothe specific details and representative embodiments shown and describedherein. Accordingly, various modifications may be made without departingfrom the spirit or scope of the general inventive concept as defined bythe appended claims and their equivalents. As used in the claims theconjunction “or” means the inclusive or (and/or, either elementindependently or any combination of the elements together).

What is claimed is:
 1. A device configured to create an effect on orgather data about a target site in a patient's brain, comprising: two ormore shafts configured to be inserted through skin, muscle, tissue,bone, or skull at an entry site; and at least one component, includingan effector or a sensor, associated with each of said two or moreshafts, each of said at least one component coupled to its associatedshaft by one or more of: being housed within, passing through, or beingattached to each of said two or more shafts; wherein the effectors areconfigured to communicate with one another either wirelessly or with aphysical connector; wherein each of said two or more shafts and itsassociated component are configured to be inserted at an angle, betweenand inclusive of parallel to a tangent of a surface at the entry siteand perpendicular to a tangent of a surface at the entry site; whereineach of said two or more shafts is configured to be inserted at theentry site at different trajectories from all other shafts; wherein eachof said two or more shafts is configured such that, when fully insertedalong a trajectory, a proximal end of the shaft passes through the entrysite, thereby allowing for another shaft to be inserted at a differenttrajectory through the entry site; wherein the diameter of the entrysite is less than the combined diameter of at least two of the effectorshafts; wherein a length of each shaft and its associated component isindependent of other shafts and their associated components and is notlimited to the thickness of the skin, muscle, tissue, bone, or skull atthe entry site; wherein the length of each shaft is selected such that,when fully inserted along the trajectory, the shaft does not pass intothe patient's brain and the length of at least one of the two or moreshafts is greater than the thickness of the skull at the entry site; andwherein the distal and proximal ends of the device are configured to befully contained within the body when the device creates an effect on orgathers data about a target site in the patient's brain.
 2. The deviceof claim 1, wherein the components, including the effector or thesensor, are selected from the group consisting of: a battery, anelectrode, a recharger, a transmitter, a receiver, a transceiver, asensor, a recorder, a capacitor, a transformer, a system control unit, aprogrammer, an address/positioning unit, a temperature sensor, atemperature adjuster, a thermogenerator, a thermoelectric generator, amechanical power generator, a photo/light generator, an ultravioletlight generator, an infrared generator, an optical stimulator, a laser,a radiofrequency generator, a magnetic field generator, a mechanicalvibration generator, an ultrasonic wave generator, an electrical fieldgenerator, a radiation generator, a fuel cell, a drug delivery unit, agene therapy delivery unit, a reservoir for drugs and radioactivesubstances, and a reservoir for substances released into a body.
 3. Thedevice of claim 1, wherein each shaft is configured to be insertedthrough skin, tissue, or bone when a pre-made hole is not present, theshaft being self-drilling and/or self-tapping.
 4. The device of claim 1,wherein the effector or the sensor communicates with the target sitesuch that effects of the effector extend to the patient's brain, orstimuli that activate the sensor are derived from the patient's brain.5. The device of claim 1, wherein the bone is a skull and a combinedlength, minus any overlap, of the shaft and its components, includingeffectors and/or sensors, results in a part of the device or itscomponents, including effectors or sensors, being placed: (i)superficial to the skull within skin, fat tissue, connective tissue,ligament, tendon, mucosa, or muscle, (ii) within bone or skull or (iii)epidurally (upon dura mater).
 6. The device of claim 5, wherein thecomponents, including effectors and/or sensors, are located on or arecomposed of a rigid, semi-rigid, or flexible housing that travelsthrough the shaft; wherein the housing is a metal, a plastic, a polymer,a mesh, a fabric, or a woven material, and wherein the shaft and/or oneor more components, on or within the flexible housing traveling throughthe shaft, is guided to the target location by one of the following or acombination of the following mechanisms: i) mechanical steering of thehousing such as an inner stylet that is steerable by having a bendabletip or that has a bend in a tip that is steerable by rotating,advancing, or withdrawing the housing and stylet; ii) magnetic steeringof the housing wherein a ferromagnetic, or electromagnetic tip of thehousing or the tip of a removable stylet within the housing is guided,steered, or moved by a magnetic field induced by a magnetic orelectromagnetic mechanism either inside or outside the body; iii)stereotactic guidance to the target where stereotactic localization isbased on one or a combination of the following techniques: MagneticResonance Imaging (MRI), functional Magnetic Resonance Imaging (fMRI),Magnetic Resonance Spectroscopy (MRS), diffusion MRI (DWI), diffusiontensor MRI (DTI), electroencephalography (EEG), magnetoencephalography(MEG), nuclear neuroimaging, positron emission tomography (PET), singlephoton emission computed tomography (SPECT), Ictal-Interictal SPECTAnalysis by Statistical Parametric Mapping (ISAS), Computed Tomography(CT), x-ray, fluoroscopy, angiography, ultrasonography, transcranialmagnetic stimulation (TMS), transcranial direct current stimulation(tDCS), transcranial electrical stimulation (TES), motor evokedpotential (MEP), somatosensory evoked potential (SSEP), phase reversalof somatosensory evoked potential, evoked potential,electrocorticography (ECoG), direct cortical electrical stimulation(DCES), microelectrode recording (MER), and local field potentialrecording (LFP); iv) endoscopic visualization and guidance.
 7. Thedevice of claim 1, further comprising a head unit attached to orassociated with an end of the first shaft, wherein the head unitcomprises one or more docking stations, each configured to receive atleast one additional component or shaft housing the component; whereinthe docking station has one or more holes or couplings therein, throughwhich one or more component(s) or shaft(s) housing these components is(are) inserted through, attached to, coupled with, or connected with thehead unit; wherein the docking stations are radially spaced around thehead unit, in order that several components or shafts housing thesecomponents may be inserted at a single common entry site through thesame head unit and directed perpendicularly downward, radially outward,or radially inward at different angles around the head unit.
 8. Thedevice of claim 7, wherein the head unit is a connector between multipleimplanted components, shafts housing these components, or devices, andwherein the head unit allows direct electrical contact between one ormore additional component(s), or shaft(s) housing these components, andthe first shaft of the device inserted through a common entry site,thereby allowing direct communication, connection, or power transferbetween the additional component(s) or shaft(s) and the first shaft. 9.The device of claim 1, wherein said effect comprises one or more of thefollowing: electrical stimulation or electrical disruption of the targetsite; mechanical stimulation or mechanical disruption of the targetsite; changing temperature at the target site; inducing a magnetic fieldat the target site; photostimulation or photoinhibition of the targetsite, including photomodulation and use of laser to stimulate or inhibita process at the target site; ultrasonic stimulation or ultrasonicdisruption of the target site; inducing a vibration that is transmittedto the target site, including a sonic vibration that is transmitted toand activates auditory receptors; creating and modulating an electricalfield for ionophoresis or iontophoresis at the target site; andirradiating the target site.
 10. The device of claim 1, wherein saiddevice is configured to gathers data by one or more of the following:monitoring signals of single neurons and of populations of neurons;monitoring intracranial pressure; monitoring physiologic signals;monitoring metabolic activity and other signals of tissues includingneurons, glial cells, blood cells, immune cells, and other cells;monitoring signals derived from cellular and sub-cellular componentsincluding proteins, DNA, RNA, molecules, neurotransmitters, hormones,and mitochondria; measurement of components, states of components, orphysical properties in a body including electrolytes, proteins,hormones, amino acids, molecules, carbohydrates, minerals, fatty acids,osmolarity, osmolality, pharmaceuticals, radioactive tracers, light,electromagnetic energy, fluorescence, radiation, and other measureableitems; monitoring optical, fluorescent, ultraviolet, infrared, and/orbirefringence signals, and/or changes therein, emitted from tissuesincluding neurons, glial cells, blood cells, other cells, blood andcerebral spinal fluid; and/or monitoring temperature of tissue andchanges thereof.
 11. The device of claim 1, wherein each said shaft hasone or more of the following properties: is straight; is curved; iscurved to follow a contour curvature of bone or skull; is curved in aspiral that skewers into the body or skull through the entry site; canchange shape during an insertion process as it is inserted; is rigid; isat least partially flexible; changes between rigid and flexible states;has a sharp tip; has a blunt tip; has a tip that is not sharp enough topuncture cortical bone; has an atraumatic curved tip that can be easilyinserted into a premade entry site; is threaded and configured to bescrewed into position; is made of a selectively permeable material thatdifferentially absorbs, transmits, repels, and elutes differentmolecules; is made of a selectively permeable material that comprisescells embedded therein; and/or is made of a selectively permeablematerial that is a nanoporous mesh.
 12. The device of claim 1, having atleast one effector, wherein the effector is encased within a protectivehousing and capable of stimulating tissue by transmitting energy throughthe housing.
 13. The device of claim 1, having at least one effector orsensor, wherein the effector or sensor protrudes out of an end of ashaft or is located on a surface of a shaft.
 14. A method of providingelectrical stimulation therapy to a patient's brain using the device ofclaim 1, having at least one electrode, comprising: implanting thedevice in the skull and generating a pulse from the electrode; whereinan insertion angle of the device is related to device length such thatwhen the device is fully inserted the length traverses entirely throughthe skull but does not penetrate into the brain.
 15. A method ofproviding electrical stimulation therapy to the body using the device ofclaim 1, having at least one electrode, comprising: implanting thedevice in the body and generating a pulse from the electrode(s); whereinthe insertion angle (θ) is related to device length (l) such that:sin θ=x/l wherein θ is measured from an axial line perpendicular to askin's surface at the entry site; and x is lateral displacement in adirection parallel to the skin's surface at the entry site when thedevice is fully inserted.
 16. A method of implanting the device of claim1, having one or more additional shaft(s) housing additional components,comprising: (i) inserting a head unit, with or without a shaft,perpendicularly to a skin's surface; (ii) inserting another shafthousing additional components through the head unit at any first anglebetween parallel and perpendicular to the skin's surface and at anysecond radial angle around the head unit; (iii) inserting one or moreadditional shafts, each shaft housing additional components, through thehead unit, at any first angle between parallel and perpendicular to theskin's surface and at any second radial angle around the head unit,wherein either the first angles or the second angles or both for any twoshafts are different, such that each shaft occupies a unique positionwith respect to the other shafts.
 17. A method of providing electricalstimulation therapy to a living body using the device of claim 1, havingat least one electrode, comprising: implanting the device in the body;and generating one or more pulses from the electrode(s); in order toprovide therapy to a patient for treatment of a condition selected fromthe group consisting of: epilepsy, stroke, movement disorders,Parkinson's Disease, tremor, multiple sclerosis, dystonia, tics,Tourette's Syndrome, stuttering, depression, pain, headache, migraineheadache, trigeminal neuralgia, facial pain, insomnia, narcolepsy,attention deficit disorder (ADD), attention deficit hyperactivitydisorder (ADHD), autism, obesity, paralysis, blindness, deafness, benigntumors of brain and body, malignant tumors of brain and body,neurodegenerative disorders, alopecia, dementia, altered consciousnessstates, psychiatric disorders (including obsessive compulsive disease,bipolar depression, anxiety, schizophrenia, neuroses, and psychoses),criminal behavior, sexual dysfunction, erectile dysfunction, andaddictions related to brain activity including addictions to thefollowing: drugs (including narcotics, pain medications, sedatives,stimulants), illicit drugs (including cocaine, marijuana, heroin,methamphetamine), prescription drugs, muscle relaxants, tobacco(smoking), alcohol, food, sex, pornography, pedophilia, gambling, thrillseeking, television, video games, and the internet.
 18. A method ofenabling communication between two or more entities, at least one entitybeing a living organism, comprising: implanting the device of claim 1,in a first entity, said first entity being part of a living organism.19. The method of claim 18, wherein the communication includes thefollowing forms: electromagnetic, acoustic, ultrasonic, and formscomprising frequencies outside a range of human hearing.
 20. The methodof claim 18, the device further comprising at least one component, suchas a receiver or transceiver, and further comprising: the receiver ortransceiver receiving input from at least one other entity; wherein saidreceiving input includes, but is not limited to, indirectly receivinginput through one or more intermediary devices that relays, modulates,and/or processes one or more signals between the entities.
 21. Themethod of claim 20, wherein the other entity is a radio, radiotransmitter, musical player, cell phone, personal digital assistant,computer, or internet.
 22. The method of claim 18, the device furthercomprising at least one component adapted to transmit, communicate, orbroadcast, such as a transmitter or transceiver, and further comprising:the transmitter or transceiver transmitting, communicating, orbroadcasting information to at least one other entity; wherein saidtransmitting, communicating, or broadcasting includes, but is notlimited to, transmitting, communicating, or broadcasting through one ormore intermediary devices that relays, modulates, and/or processes oneor more signals between the entities.
 23. The method of claim 18, thedevice further comprising at least one component adapted to receive,such as a receiver or transceiver, and/or at least one component adaptedto transmit, such as a transmitter or transceiver, and furthercomprising: implanting at least one additional component or identifyinga receiver capability in a second entity; gathering data or signals inthe first entity with a sensor of the device; transmitting these data orsignals to the second entity; and receiving these data or signals fromthe first entity in the second entity through the additional componentor through an already present receiver capability in the second entity.24. The method of claim 23, further comprising: a second entitycommunicating or responding to the first entity by transmittingdata/signals to the first entity, resulting in the effector of a devicein the first entity generating a signal in the first entity, includingwhen the device in the first entity that receives the data/signals fromthe second entity is a different device in a different location than thedevice in the first entity that transmits data or signals to the secondentity, wherein this form of communication between two or more entitiesis two-way, recurrent, reciprocal, or closed-loop communication.
 25. Themethod of claim 24, the device in the first entity further comprising atleast one feedback component, and further comprising: upon the firstentity transmitting data or signals to the second entity; the secondentity verifying receipt of the data or signals transmission by sendinga response, feedback, or verification signal to the first entity andthereby facilitating closed loop communication between two or moreentities.
 26. The method of claim 25, wherein the verification step,involving the second entity sending a feedback signal to the firstentity, is contingent on an effect in the second entity, such asgeneration or induction of a specific signal/response or completion of adesired task.
 27. The method of claim 18, further comprising: gatheringdata by a sensor on the device in the first entity; and communicatingthe data to one or more second entities; wherein the data relates toneuronal activity or physiological parameters.
 28. The method of claim23, further comprising: initiating the transmission, from the firstentity to the second entity, through a signal in the first entity;wherein the signal is induced by: activation of an effector of a device,electrode stimulation, vibrations, alterations intemperature/pressure/light, patterns of neural activity, and/or changesin cellular activity.
 29. The method of claim 23, further comprising: atleast one component in the second entity recognizing specific signals asbeing from certain other entities.
 30. The method of claim 23, furthercomprising: at least one component in the second entity interpretingspecific signals as indicating certain conditions.
 31. The method ofclaim 23, wherein the second entity is a different part of the sameliving organism of which the first entity is a part.
 32. The method ofclaim 18, wherein a second entity involved in the communication is alsoa living organism.
 33. The method of claim 18, wherein a second entityinvolved in the communication is a machine.
 34. The method of claim 33,wherein the machine is selected from the group consisting of one or moreof the following: a computer, a cell phone, a phone, a personal digitalassistant, a muscle stimulator, a wheelchair, a motorized vehicle, arobot, and an electronic circuit.
 35. A method of providing electricalstimulation therapy using at least two of the devices of claim 1, eachdevice having at least one electrode as the effector, comprising:implanting a first device through the skull at a first entry site;implanting a second device through the skull at a second entry site;generating a pulse from at least one electrode on the first device; andgenerating a pulse from at least one electrode on the second device;wherein the target site is in a brain of a patient between a center ofthe brain and the skull, and an orientation of at least one electrode onthe first device and at least one electrode on the second device areselected so that at least one electrode from each device is directed atthe target site.
 36. The device of claim 1, wherein at least one of thecomponents is disposed on or comprises a semi-rigid or flexible housingconfigured to travel through the shaft and slide within an epidural orsubdural space.
 37. The device of claim 36, wherein the housing isconfigured to be guided to the target location via mechanical steering,magnetic steering via a ferromagnetic or electromagnetic tip of thehousing, stereotactic guidance, or endoscopic visualization andguidance.
 38. The device of claim 1, wherein at least one of the shaftsis semi-flexible and configured to slide within the cancellous space ofthe skull.
 39. The device of claim 1, wherein each of the two or moreshafts is configured to be directly embedded within and in contact withthe skull.
 40. The device of claim 39, wherein the two or more shaftsare configured to be inserted at divergent angles from the entry sitewithin the skull.
 41. The device of claim 39, wherein a diameter of eachof the two or more shafts is less than the thickness of the skull. 42.The device of claim 39, wherein a diameter of each of the two or moreshafts is less than 5 mm.
 43. The device of claim 1, wherein an area ofthe target site is greater than an area of the entry site.